The Ministry of Food and Drug Safety (Minister: Yu-Kyung Oh) issued a pre-announcement of administration on September 6th regarding the amendment of the ‘Regulations on Renewal of Medical Device Manufacturing Permits.’ and will be receiving opinions until September 26th. The amendment contains changes such as requiring different data submissions for each medical device in consideration of each device’s characteristics to ensure the smooth operation of the medical device product renewal system that will be implemented in 2025.

The medical device permit renewal system was introduced to periodically check the safety and effectiveness of products that have already been approved, reported, and certified,